Heidelberg Institute of Global Health, Heidelberg, 69120, Germany.
Max-Weber-Institute of Sociology, Heidelberg, Germany.
F1000Res. 2021 Feb 11;10:102. doi: 10.12688/f1000research.51312.1. eCollection 2021.
Broad consent for future use is the reuse of data and/or samples collected by a study by researchers who may not be affiliated with the original study team for purposes that may differ from the objectives of the original study. Sharing participant-level data and samples collected from research participants facilitates reuse and transparency and can accelerate drug or vaccine development, research findings, and translation. Data reuse and synthesis help prevent unnecessary research, thereby respecting research participants time and efforts and building their trust in the research process. Despite these myriad benefits, data and sample sharing represent a significant investment of time for the team that collected the data or samples, and may present additional risks for research participants, including that of re-identifiability and incidental findings, or for the source community. This scoping review will summarize existing guidance on broad consent for future use and highlight evidence gaps related to the ethical, equitable implementation of broad consent for future use. We will apply the Arskey and O'Malley scoping review methodology and best practice as outlined in the Joanna Briggs scoping review guidelines. The research questions have been identified through a literature review and consultation with subject-matter experts. The systematic search will be conducted in three databases using a tailored search strategy. We will search the reference lists of included articles or related systematic reviews for additional citations. The title-abstract and full text screening and charting the data will be conducted independently by two reviewers. Discrepancies will be resolved by a third reviewer. Results will be summarized in narrative form. This scoping review summarizes findings from existing publications and grey literature rather than primary data and, as such, does not require ethics review. Findings will be disseminated through an open access publication and webinar.
广泛同意将来使用是指研究人员对研究收集的数据和/或样本进行再利用，这些研究人员可能与原始研究团队没有隶属关系，其目的可能与原始研究的目标不同。共享来自研究参与者的参与者级别的数据和样本，促进了再利用和透明度，并可以加速药物或疫苗的开发、研究结果和转化。数据再利用和综合有助于防止不必要的研究，从而尊重研究参与者的时间和努力，并建立他们对研究过程的信任。尽管有这些好处，但数据和样本共享代表了收集数据或样本的团队的重大时间投入，并且可能会给研究参与者带来额外的风险，包括重新识别和偶然发现的风险，或者对来源社区的风险。这项范围综述将总结现有的关于未来使用的广泛同意的指导意见，并强调与未来使用的广泛同意的伦理、公平实施相关的证据差距。我们将应用 Arskey 和 O'Malley 的范围综述方法和 Joanna Briggs 范围综述指南中概述的最佳实践。研究问题是通过文献综述和与主题专家的协商确定的。系统搜索将在三个数据库中使用定制的搜索策略进行。我们将在纳入文章或相关系统综述的参考文献列表中搜索其他引用。标题-摘要和全文筛选以及数据图表制作将由两名评审员独立进行。有分歧的地方将由第三名评审员解决。结果将以叙述的形式进行总结。这项范围综述总结了现有出版物和灰色文献的发现，而不是原始数据，因此不需要伦理审查。研究结果将通过开放获取出版物和网络研讨会进行传播。
